Alcohol Abuse, Nervous SystemPhase 2PoC AlcoholNCT02800083
A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment
A Phase 2 study testing Pitolisant (BF2.649) in people with Alcohol Abuse, Nervous System, run by Bioprojet.
Trial summary
The study primary end point is the decrease in the number of monthly heavy drinking days (HDD) (≥ 60 g/day in men and ≥ 40 g/d in women) from baseline to the end of the double blind Randomized Treatment (RT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Abuse, Nervous System
- What is being tested?
- Pitolisant (BF2.649)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI Plus)
- Ages 18-65.
- Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale <10 at baseline assessment
- Normal weight: 18 kg/m2 ≤ BMI ≤ 35 kg/m2.
- Excessive alcohol use: number of heavy drinking days (≥ 60 g/day in men and ≥ 40 g/d in women) ≥15 during 30 days prior to screening and ≥7 during the 2 weeks between screening and baseline.
- Treatment-seeking, treatment goal: reduced drinking or abstinence
Show all 10Show fewer
- If fertile, both males and females must agree to use effective birth control. Females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding.
- Adequate social support according to the investigator to comply with the study requirements described in the protocol (e.g. transportation to and from trial site, self-rating scales, drug compliance, scheduled visits, etc.).
- Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC<0.05).
- Willing to receive psychosocial support
Who cannot join
- History of delirium tremens, epilepsy, or withdrawal seizures
- Clinical depression or suicidality: Beck Depression Inventory (BDI) < 16 and suicidality (Item G =0)
- Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids.
- Clinically significant cardiovascular, hematologic, severe hepatic impairment or (FLTs> 3 ULN), renal (Stage 2 and 3 according to international classification of renal kidney disease), neurological, endocrinological abnormalities or abnormal clinical laboratory results (in most cases > 3ULN).
- History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes.
- HIV positive; HCV positive; HBsAg positive
Show all 16Show fewer
- History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse
- Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox.
- Receiving ongoing alcohol use disorder medication (e.g. Baclofen)
- Other active clinically significant illness, which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study participation.
- Known history of syncope, arrhythmia, myocardial infarction or any known significant ECG abnormality
- Known hypersensitivity to the tested treatment including active substance and excipients.
- Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator.
- Insufficient medical insurance according to local regulations.
- Pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit or lactating women
- Male subject who wants to conceive a child during the duration of the study.
About this study
Official title: A Multisite Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Pitolisant (BF2.649) For Alcohol Use Disorder Treatment
- The study primary end point is the decrease in the number of monthly heavy drinking days (HDD) (≥ 60 g/day in men and ≥ 40 g/d in women) from baseline to the end of the double blind Randomized Treatment (RT).
- The Secondary end points will be designed to assess safety and tolerability and to further investigate the effect of pitolisant on other alcohol use criteria (e.g. total alcohol consumption, number of abstinence days), craving as well as the improvement in mental health (depression, sleep) and quality of life.
- Total alcohol consumption (TAC) from baseline to end of treatment. TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
- Percent of patients without HDDs during the 24 weeks RT phase of the study. (Continuous Controlled Drinking=CCD)
- Percent of Abstinent Days during RT phase (PAD)
- Continuous Abstinence Duration from baseline during 24 weeks RT phase (CAD)
- 4-week point prevalence abstinence at end of treatment
- Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24 week RT phase
- Craving (Obsessive Compulsive Drinking Scale) during 24 week RT phase
- Beck Depression Inventory (BDI) during 24 week RT phase
- Quality of sleep (Pittsburgh Sleep Quality Index) during RT phase.
- Treatment retention during 24 week RT
- Quality of life (SF-12) during RT phase
- Percent patients without HDDs during the OL follow up period
- Quality of life (SF-12) during OL phase
- Quality of sleep (Pittsburgh Sleep Quality Index) during OL phase
- Treatment retention OL phase Safety will be assessed by evaluation of treatment emergent adverse events (TEAE), physical examinations, clinical laboratory tests (blood chemistry, hematology, and urinalysis), subsequent end of treatment potential withdrawal, evaluation scales and physical examination, measurement of heart rate, blood pressure, and body weight at each study visit )V0-FU5). If at ECG Fridericia's corrected QT interval ≥ 500 ms or if difference to baseline is ≥ 60 ms it will be required to check ECG by second measurement after lying down 10 minutes.
- Conditions
- Alcohol Abuse, Nervous System
- Being tested
- Pitolisant (BF2.649), Placebo
- Medical subject headings
- Alcohol-Induced Disorders, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitolisant (BF2.649)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pitolisant (BF2.649) | Experimental | Histamine H3 receptor H3R antagonist/ inverse agonist Receives: Drug: Pitolisant (BF2.649) |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Heavy Drinking Days (HDD/month)
Measured: Change from Baseline of Monthly Heavy Drinking Days and at week 24
Secondary outcomes (9)
Total daily Alcohol Consumption (TAC)
Measured: at week 24 versus Baseline
Percent of Abstinent Days during 24 weeks medication phase (PAD)
Measured: at week 24 versus Baseline
Improvement in alcohol biomarkers (ALAT, ASAT, % CDT)
Measured: at baseline , at week 4 , at week 8, at week 12, at week 16, at week 20 and at week 24. versus Baseline
Continuous Abstinence Duration during 24 weeks medication phase (CAD)
Measured: at week 24 versus Baseline
Obsessive Compulsive Drinking Scale (OCDC)
Measured: at week 24 versus Baseline
Time Line Follow Back (TLFB)
Measured: at week 24 versus Baseline
Alcohol Use Disorders Identification Test (AUDIT)
Measured: at week 24 versus Baseline
Pittsburgh Sleep Quality Index (PSQI)
Measured: at week 24 versus Baseline
Quality of Life (SF-12)
Measured: at week 24 versus Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Abuse, Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800083
- Sponsor's protocol ID
- P15-14/BF2.649
- Acronym
- PoC Alcohol
- Status last verified
- Jun 2016
- First submitted
- 7 Jun 2016
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multisite Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Pitolisant (BF2.649) For Alcohol Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT02800083
- Acronym / sponsor ID
- PoC Alcohol / P15-14/BF2.649
- Conditions
- Alcohol Abuse, Nervous System
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The study primary end point is the decrease in the number of monthly heavy drinking days (HDD) (≥ 60 g/day in men and ≥ 40 g/d in women) from baseline to the end of the double blind Randomized Treatment (RT).
- The Secondary end points will be designed to assess safety and tolerability and to further investigate the effect of pitolisant on other alcohol use criteria (e.g. total alcohol consumption, number of abstinence days), craving as well as the improvement in mental health (depression, sleep) and quality of life.
- Total alcohol consumption (TAC) from baseline to end of treatment. TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
- Percent of patients without HDDs during the 24 weeks RT phase of the study. (Continuous Controlled Drinking=CCD)
- Percent of Abstinent Days during RT phase (PAD)
- Continuous Abstinence Duration from baseline during 24 weeks RT phase (CAD)
- 4-week point prevalence abstinence at end of treatment
- Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24 week RT phase
- Craving (Obsessive Compulsive Drinking Scale) during 24 week RT phase
- Beck Depression Inventory (BDI) during 24 week RT phase
- Quality of sleep (Pittsburgh Sleep Quality Index) during RT phase.
- Treatment retention during 24 week RT
- Quality of life (SF-12) during RT phase
- Percent patients without HDDs during the OL follow up period
- Quality of life (SF-12) during OL phase
- Quality of sleep (Pittsburgh Sleep Quality Index) during OL phase
- Treatment retention OL phase Safety will be assessed by evaluation of treatment emergent adverse events (TEAE), physical examinations, clinical laboratory tests (blood chemistry, hematology, and urinalysis), subsequent end of treatment potential withdrawal, evaluation scales and physical examination, measurement of heart rate, blood pressure, and body weight at each study visit )V0-FU5). If at ECG Fridericia's corrected QT interval ≥ 500 ms or if difference to baseline is ≥ 60 ms it will be required to check ECG by second measurement after lying down 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitolisant (BF2.649) | Experimental | Drug: Pitolisant (BF2.649)Histamine H3 receptor H3R antagonist/ inverse agonist |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI Plus)
- Ages 18-65.
- Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale <10 at baseline assessment
- Normal weight: 18 kg/m2 ≤ BMI ≤ 35 kg/m2.
- Excessive alcohol use: number of heavy drinking days (≥ 60 g/day in men and ≥ 40 g/d in women) ≥15 during 30 days prior to screening and ≥7 during the 2 weeks between screening and baseline.
Key exclusion criteria (16 listed)
- History of delirium tremens, epilepsy, or withdrawal seizures
- Clinical depression or suicidality: Beck Depression Inventory (BDI) < 16 and suicidality (Item G =0)
- Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids.
- Clinically significant cardiovascular, hematologic, severe hepatic impairment or (FLTs> 3 ULN), renal (Stage 2 and 3 according to international classification of renal kidney disease), neurological, endocrinological abnormalities or abnormal clinical laboratory results (in most cases > 3ULN).
- History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitolisant (BF2.649) | Drug | Pitolisant (BF2.649) |
| Placebo | Drug | Placebo |
Primary outcome
Monthly Heavy Drinking Days (HDD/month)
Time frame: Change from Baseline of Monthly Heavy Drinking Days and at week 24
9 secondary outcomes
Total daily Alcohol Consumption (TAC)
Time frame: at week 24 versus Baseline
Percent of Abstinent Days during 24 weeks medication phase (PAD)
Time frame: at week 24 versus Baseline
Improvement in alcohol biomarkers (ALAT, ASAT, % CDT)
Time frame: at baseline , at week 4 , at week 8, at week 12, at week 16, at week 20 and at week 24. versus Baseline
Continuous Abstinence Duration during 24 weeks medication phase (CAD)
Time frame: at week 24 versus Baseline
Obsessive Compulsive Drinking Scale (OCDC)
Time frame: at week 24 versus Baseline
Time Line Follow Back (TLFB)
Time frame: at week 24 versus Baseline
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: at week 24 versus Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: at week 24 versus Baseline
Quality of Life (SF-12)
Time frame: at week 24 versus Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
Related trials for Alcohol Abuse, Nervous System
RecruitingPhase 2/3
Alcohol Use Disorder and Cannabidiol
Alcohol Use Disorder
Recruiting
Virtual Incentive Treatment for Alcohol
Alcohol Use Disorder, Alcohol Drinking
Active, not recruitingObservational study
The Norwegian Addiction, Pain and Trauma Study
Chronic Pain, Post-traumatic Stress Disorder
Not yet recruitingPhase 2
A Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder
Alcohol Abuse, Alcohol Abuse/addiction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pitolisant (BF2.649) in people with Alcohol Abuse, Nervous System, run by Bioprojet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly Heavy Drinking Days (HDD/month) (time frame: Change from Baseline of Monthly Heavy Drinking Days and at week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.